510(k) K971296 ยท ESD Hearing Aid, Air-Conduction, Prescription
TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05
| Applicant | National Hearing Aid Dist., Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Jun 20, 1997 |
| Received | Apr 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971296
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.